I. Field of the Invention
The present invention is directed generally to a simplified adjustably fastened, quickly positioned external pressure delivery device for applying varying amounts of localized external pressure to a selected region of the body. More particularly, the invention relates to a portable, wearable vascular compression device for promoting hemostasis at the site of a puncture after a vascular catheterization procedure has been performed which applies adjustable localized pressure at the exact site of interest for a required time that minimizes interference with patient mobility. The device and method are particularly suited to access the radial artery in the forearm.
II. Related Art
Today, numerous medical procedures for the purpose of both diagnosis and treatment are undertaken and enabled by navigation of the vascular system of the patient. These procedures are performed in connection with diseases of the vessel system including heart catheterization and angiography and the investigation or treatment of other malformations or diseases in organs, such as the brain or kidneys. Each such procedure typically begins with the provision of a small incision in the accessing artery or vein using a small diameter cannula. A guide catheter device is normally inserted into the cannula extending into the arterial or venial passage of interest, and the operative catheter is thereafter threaded over the guide device into the vascular system. After the procedure is completed, the catheter is withdrawn and the guide and cannula removed, leaving a wound including an arterial or venial incision which will bleed profusely unless the bleeding is stopped for a sufficient length of time such that clotting occurs and the vascular passage recovers sufficiently that it can again withstand normal blood pressure without leaking. Bleeding has long been arrested manually by the physician or other health professional by applying a compressive bandage utilizing one or more fingers and holding the compress in place manually for a time up to about one-half hour. This is a time-consuming menial task for the health professional and the application of a steady pressure is most difficult and fatiguing.
For some time, many of these procedures have been undertaken via a femoral artery or vein in the groin of the patent. In this regard, several devices have been proposed which address the application of pressure to accomplish hemostasis of a femoral artery or vein following such procedures. One such device is found in published PCT Application WO92/21297, published 10 Dec. 1992, which describes an apparatus for closing operation wounds after the puncturing of a femoral vessel (vein or artery) which has a head-mounted displaceably in a vertical direction on a swing arm of an upright member which, in turn, is fastened to the frame of a hospital bed. This device is quite large, expensive and cumbersome to use and requires the patient to lie immobile in the prone position for the entire time the device is used.
Another device for post-catheterization hemostasis is found in U.S. Pat. No. 4,957,105. This device utilizes hip straps which lead from a pelvic apron up over the hips and over an opposing lip so that tensile force is applied to the femoral site as by a groin strap. An additional device, found in U.S. Pat. No. 5 307 811, includes a belt or strap for fastening around the patient in conjunction with a shaped two-part, slidably-extendable base plate which supports fixed, inflated pressure applying appurtenance attached to the inner or lower side of the relatively rigid base plate. The device is configured to specifically address the frontal femoral region, the belt enclosing the entire body of the patient. That device does not enclose the patient other than by virtue of the strap; and it is apparent that the location of the device will remain stable only as long as the patient remains immobilized in a prone position. Otherwise, the strap may slip out of place and dislodge the device.
The present state of such devices clearly indicates the need for the provision of a vascular compression device that is simpler in construction, easier to apply and more versatile in its use. In addition, because available devices that compress the femoral region generally result in compression that is debilitating to the patient, the trend among physicians has been toward greater use of vessels in the arm, such as the radial artery, to allow the patient to perambulate directly after the procedure. Unfortunately, the state-of-the-art with respect to hemostasis in the radial artery involves the use of a tourniquet which cuts off all blood supply to the distal limb--a most undesirable situation which needs to be addressed by a new device. Thus, a need clearly is present for a device that would be less debilitating and adaptable to perform vascular compression at a variety of puncture sites which might be utilized to access the vascular system of the patient, including particularly the radial artery in the forearm or wrist.
Accordingly, it is a primary object of the present invention to provide a low cost device for applying varying degrees of localized external pressure to a bodily region of interest such as the site of a vascular intervention procedure that is of relatively simple construction and which minimizes interference with patient mobility and activities.
A further object of the present invention is to provide a wearable compression device for selectively applying compressive force to a localized surface region of interest in the body that is readily adjustable and portable.
A still further object of the present invention is to provide a compression device for selectively applying varying degrees of compressive pressure force to a localized surface region of interest in the body which does not otherwise impair circulation.
A yet still further object of the invention is to provide a method for selectively compressing a region overlying a vascular structure which minimizes the time required for the health professional to apply, attend and remove.
Another object of the present invention is to provide a device for selectively applying varying degrees of external pressure to a localized area of the forearm or wrist to promote hemostasis in the radial artery.
Other objects and advantages associated with the invention will occur to those skilled in the art in conjunction with further study of this specification and claims.